Palabras clave
Acupuntura; placebo; doble ciego; IG4; medicina china.
Cómo citar
Validación de un nuevo método de acupuntura placebo con potencial doble ciego. Fase II: cegamiento del operador: Phase II: practitioner blinding. (2018). Odontoestomatología, 20(32). https://odon.edu.uy/ojs/index.php/ode/article/view/235
Resumen
Se presenta un nuevo método de acupuntura placebo, evaluándose en esta fase el cegamiento del operador. Metodología: Se implementaron dos estudios experimentales utilizando como referencia el punto acupuntural Intestino Grueso 4 (IG4). En el primero (I) tres operadores utilizaron el dispositivo desarrollado en un mismo paciente. Mientras que en un segundo experimento (II), un único acupunturista utilizó dicho dispositivo en 12 voluntarios sanos. Resultados: En I, sobre un total de 30 agujas que utilizaron los operadores, estos pudieron identificar correctamente 7 (23%). Por otra parte, en el experimento II, los porcentajes de acierto encontrados no fueron significativamente diferentes de 50%, por lo cual no hay evidencia suficiente que permita decir que el acupunturista reconoce el tipo de aguja que está utilizando. Conclusiones: El nuevo dispositivo evidenció un alto potencial de cegamiento del operador, sugiriendo que es útil para enmascarar incluso a acupunturistas experimentados.
Referencias
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2. Yang ES, Li PW, Nilius B, Li G. Ancient Chinese medicine and mechanistic evidence of acupuncture physiology. Pflugers Arch Eur J Physiol. 2011; 462 (5): 645-653. doi:10.1007/s00424-011-1017-3
3. Leung L. Neurophysiological Basis of Acupuncture-induced Analgesia: An Updated Review. JAMS J Acupunct Meridian Stud. 2012; 5 (6): 261-270. doi:10.1016/j.jams.2012.07.017
4. Cheng KJ. Neurobiological Mechanisms of Acupuncture for Some Common Illnesses: A Clinician's Perspective. JAMS J Acupunct Meridian Stud. 2014;7 (3): 105-114. doi:10.1016/j.jams.2013.07.008
5. Kaptchuk TJ. Acupuncture?: Theory , Efficacy , and Practice. Ann Intern Med. 2002; 136 (5): 374-83
6. Schulz K, Douglas AG, Moher D. CONSORT 2010 Statement: Updated Guidelines for Reporting Parallel Group Randomised Trials. Br Med J. 2010; 340:698-702. doi:10.1136/bmj.c332
7. Lin J-G, Chen C-H, Huang Y-C, Chen Y-H. How to Design the Control Group in Randomized Controlled Trials of Acupuncture? Evidence-Based Complement Altern Med. 2012; 2012: 1-7. doi:10.1155/2012/875284
8. Vas J, Perea-Milla E, Méndez C, Sánchez Navarro C, León Rubio JM, Brioso M, García Obrero I. Efficacy and safety of acupuncture for chronic uncomplicated neck pain: A randomised controlled study. Pain. 2006; 126(1-3): 245-255. doi:10.1016/j.pain.2006.07.002
9. Irnich D, Behrens N, Molzen H, König A, Gleditsch J, Krauss M, Natalis M, Senn E, Beyer A, Schöps P. Randomised trial of acupuncture compared with conventional massage and "sham" laser acupuncture for treatment of chronic neck pain. BMJ. 2001; 322 (7302): 1574-1578. doi:10.1055/s-2003-41566
10. Diraçoglu D, Vural M, Karan A, Aksoy C. Effectiveness of dry needling for the treatment of temporomandibular myofascial pain: A double-blind, randomized, placebo controlled study. J Back Musculoskelet Rehabil. 2012; 25 (4): 285-290. doi:10.3233/BMR-2012-0338
11. Cho S-Y, Lee D-H, Shin HS, Hwan Lee S, Seok Koh J, Woo-Sang J, Kwan Moon S, Mi Park J, Chang-Nam K, Ho K Park S. The efficacy and safety of acupuncture for cerebral vasospasm after subarachnoid hemorrhage: study protocol for a randomized controlled trial. Trials. 2015; 16 (1): 68. doi:10.1186/s13063-015-0591-7
12. Liang Z, Zhu X, Yang X, Fu W, Lu A. Assessment of a traditional acupuncture therapy for chronic neck pain: A pilot randomised controlled study. Complement Ther Med. 2011; 19 (SUPPL. 1):S26-S32. doi:10.1016/j.ctim.2010.11.005
13. Linde K, Streng A, Jürgens S, Hoppe A, Brinkhaus B, Witt C, Wagenpfeil S, Pfaffenrath V, Hammes MG, Weidenhammer W, Willich SN, Melchart D. Acupuncture for patients with migraine: A randomized controlled trial. J Am Med Assoc. 2005; 293 (17): 2118-2125. doi:10.1001/jama.293.17.2118
14. Kim H-M, Cho S-Y, Park SU, Sohn IS, Jung WS, Moon SK, Park JM, Ko CN, Cho KH. Can Acupuncture Affect the Circadian Rhythm of Blood Pressure? A Randomized, Double-Blind, Controlled Trial. J Altern Complement Med. 2012; 18 (10): 918-923. doi:10.1089/acm.2011.0508
15. Park J, Kim HS, Lee SM, Yoon K, Kim WS, Woo JS, Lee S, Kim JB, Kim W. Acupuncture antiarrhythmic effects on drug refractory persistent atrial fibrillation: Study protocol for a randomized, controlled trial. Evidence-based Complement Altern Med. 2015;2015. doi:10.1155/2015/613970
16. Zhang CS, Tan HY, Zhang GS, Zhang AL, Xue CC, Xie YM. Placebo devices as effective control methods in acupuncture clinical trials: A systematic review. PLoS One. 2015; 10 (11): 1-22. doi:10.1371/journal.pone.0140825
17. Lund I, Näslund J, Lundeberg T. Chinese Medicine. 2009; 9:1-9. doi:10.1186/1749-8546-4-1
18. Olausson H, Lamarre Y, Backlund H, Morin C, Wallin BG, Starck G, Ekholm S, Strigo I, Worsley K, Vallbo AB, Bushnell MC. Unmyelinated tactile afferents signal touch and project to insular cortex. Nat Neurosci. 2002; 5 (9): 900-904. doi:10.1038/nn896
19. Olausson H, Wessberg J, Morrison I, McGlone F, Vallbo Å. The neurophysiology of unmyelinated tactile afferents. Neurosci Biobehav Rev. 2010; 34 (2): 185-191. doi:10.1016/j.neubiorev.2008.09.011
20. Melchart D, Linde K, Streng A, Reitmayr S, Hoppe A, Brinkhaus B, Becker-Witt C, Wagenpfeil S, Pfaffenrath V, Hammes M, Willich SN, Weidenhammer W. Acupuncture Randomized Trials (ART) in patients with migraine or tension-type headache--design and protocols. Forsch Komplementarmed Klass Naturheilkd. 2003; 10 (4): 179-184. doi:73473
21. Lundeberg T, Lund I, Näslund J, Thomas M. The Emperor's sham - Wrong assumption that sham needling is sham. Acupunct Med. 2008; 26 (4): 239-242. doi:10.1136/aim.26.4.239
22. Birch S. Sham acupuncture is not a placebo treatment - implications and problems in research. Japanese Acupunct Moxibustion. 2012; 8 (1): 4-8.
23. Park J, White A, Lee H, Ernst E. Development of a new sham needle. Acupunct Med. 1999; 17 (2): 110-112. doi:10.1136/aim.17.2.110
24. Streitberger K, Kleinhenz J. Introducing a placebo needle into acupuncture research. Lancet. 1998; 352 (9125): 364-365. doi:10.1016/S0140-6736(97)10471-8
25. Kreiner M, Zaffaroni A, Alvarez R, Clark G. Validation of a simplified sham acupuncture technique for its use in clinical research: A randomised, single blind, crossover study. Acupunct Med. 2010; 28 (1): 33-36. doi:10.1136/aim.2009.001735
26. Takakura N, Yajima H. A placebo acupuncture needle with potential for double blinding - A validation study. Acupunct Med. 2008; 26 (4): 224-230. doi:10.1136/aim.26.4.224
27. Kim S. Creating an instrument for a successful double-blind acupuncture placebo. JAMS J Acupunct Meridian Stud. 2008; 1 (1):36-41. doi:10.1016/S2005-2901(09)60005-4
28. Takakura N, Takayama M, Kawase A, Yajima H. Double blinding with a new placebo needle: A validation study on participant blinding. Acupunct Med. 2011; 29 (3): 203-207. doi:10.1136/aim.2010.002857
29. Takayama M, Yajima H, Kawase A, Homma I, Izumizaki M, Takakura N. The Potential of Double Blinding with Two Placebo Acupuncture Needles: A Randomized Controlled Pilot-Trial. Medicines. 2014; 2 (1): 11-27. doi:10.3390/medicines2010011
30. Zhu D, Gao Y, Chang J, Kong J. Placebo acupuncture devices: Considerations for acupuncture research. Evidence-based Complement Altern Med. 2013; 2013. doi:10.1155/2013/628907
31. Takakura N, Takayama M, Kawase A, Yajima H, Streitberger K. Tapping-in method (Skin Penetration Technique) with a placebo needle for double-blind acupuncture trials. Dtsch Zeitschrift fur Akupunkt. 2013;56 (3): 25-26. doi:10.1016/j.dza.2013.09.008
32. McManus C a, Schnyer RN, Kong J, Nguyen LT, Hyun Nam B, Goldman R, Stason WB, Kaptchuk TJ. Sham acupuncture devices--practical advice for researchers. Acupunct Med. 2007; 25 (1-2): 36-40. doi:10.1136/AIM.25.1-2.36
33. Rebhorn C, Breimhorst M, Buniatyan D, Vogel C, Birklein F, Eberle T. The efficacy of acupuncture in human pain models: A randomized, controlled, double-blinded study. Pain. 2012; 153 (9): 1852-1862. doi:10.1016/j.pain.2012.05.026
34. Park J, White A, Stevinson C, Ernst E, James M. Validating a new sham (placebo) acupuncture device: two randomized controlled trials. Acupunct Med. 2002;20 (2-3): 123-123. doi:10.1136/aim.20.2-3.123
35. To M, Alexander C. The effects of Park sham needles: a pilot study. J Integr Med. 2015; 13 (1): 20-24. doi:10.1016/S2095-4964(15)60153-4
2. Yang ES, Li PW, Nilius B, Li G. Ancient Chinese medicine and mechanistic evidence of acupuncture physiology. Pflugers Arch Eur J Physiol. 2011; 462 (5): 645-653. doi:10.1007/s00424-011-1017-3
3. Leung L. Neurophysiological Basis of Acupuncture-induced Analgesia: An Updated Review. JAMS J Acupunct Meridian Stud. 2012; 5 (6): 261-270. doi:10.1016/j.jams.2012.07.017
4. Cheng KJ. Neurobiological Mechanisms of Acupuncture for Some Common Illnesses: A Clinician's Perspective. JAMS J Acupunct Meridian Stud. 2014;7 (3): 105-114. doi:10.1016/j.jams.2013.07.008
5. Kaptchuk TJ. Acupuncture?: Theory , Efficacy , and Practice. Ann Intern Med. 2002; 136 (5): 374-83
6. Schulz K, Douglas AG, Moher D. CONSORT 2010 Statement: Updated Guidelines for Reporting Parallel Group Randomised Trials. Br Med J. 2010; 340:698-702. doi:10.1136/bmj.c332
7. Lin J-G, Chen C-H, Huang Y-C, Chen Y-H. How to Design the Control Group in Randomized Controlled Trials of Acupuncture? Evidence-Based Complement Altern Med. 2012; 2012: 1-7. doi:10.1155/2012/875284
8. Vas J, Perea-Milla E, Méndez C, Sánchez Navarro C, León Rubio JM, Brioso M, García Obrero I. Efficacy and safety of acupuncture for chronic uncomplicated neck pain: A randomised controlled study. Pain. 2006; 126(1-3): 245-255. doi:10.1016/j.pain.2006.07.002
9. Irnich D, Behrens N, Molzen H, König A, Gleditsch J, Krauss M, Natalis M, Senn E, Beyer A, Schöps P. Randomised trial of acupuncture compared with conventional massage and "sham" laser acupuncture for treatment of chronic neck pain. BMJ. 2001; 322 (7302): 1574-1578. doi:10.1055/s-2003-41566
10. Diraçoglu D, Vural M, Karan A, Aksoy C. Effectiveness of dry needling for the treatment of temporomandibular myofascial pain: A double-blind, randomized, placebo controlled study. J Back Musculoskelet Rehabil. 2012; 25 (4): 285-290. doi:10.3233/BMR-2012-0338
11. Cho S-Y, Lee D-H, Shin HS, Hwan Lee S, Seok Koh J, Woo-Sang J, Kwan Moon S, Mi Park J, Chang-Nam K, Ho K Park S. The efficacy and safety of acupuncture for cerebral vasospasm after subarachnoid hemorrhage: study protocol for a randomized controlled trial. Trials. 2015; 16 (1): 68. doi:10.1186/s13063-015-0591-7
12. Liang Z, Zhu X, Yang X, Fu W, Lu A. Assessment of a traditional acupuncture therapy for chronic neck pain: A pilot randomised controlled study. Complement Ther Med. 2011; 19 (SUPPL. 1):S26-S32. doi:10.1016/j.ctim.2010.11.005
13. Linde K, Streng A, Jürgens S, Hoppe A, Brinkhaus B, Witt C, Wagenpfeil S, Pfaffenrath V, Hammes MG, Weidenhammer W, Willich SN, Melchart D. Acupuncture for patients with migraine: A randomized controlled trial. J Am Med Assoc. 2005; 293 (17): 2118-2125. doi:10.1001/jama.293.17.2118
14. Kim H-M, Cho S-Y, Park SU, Sohn IS, Jung WS, Moon SK, Park JM, Ko CN, Cho KH. Can Acupuncture Affect the Circadian Rhythm of Blood Pressure? A Randomized, Double-Blind, Controlled Trial. J Altern Complement Med. 2012; 18 (10): 918-923. doi:10.1089/acm.2011.0508
15. Park J, Kim HS, Lee SM, Yoon K, Kim WS, Woo JS, Lee S, Kim JB, Kim W. Acupuncture antiarrhythmic effects on drug refractory persistent atrial fibrillation: Study protocol for a randomized, controlled trial. Evidence-based Complement Altern Med. 2015;2015. doi:10.1155/2015/613970
16. Zhang CS, Tan HY, Zhang GS, Zhang AL, Xue CC, Xie YM. Placebo devices as effective control methods in acupuncture clinical trials: A systematic review. PLoS One. 2015; 10 (11): 1-22. doi:10.1371/journal.pone.0140825
17. Lund I, Näslund J, Lundeberg T. Chinese Medicine. 2009; 9:1-9. doi:10.1186/1749-8546-4-1
18. Olausson H, Lamarre Y, Backlund H, Morin C, Wallin BG, Starck G, Ekholm S, Strigo I, Worsley K, Vallbo AB, Bushnell MC. Unmyelinated tactile afferents signal touch and project to insular cortex. Nat Neurosci. 2002; 5 (9): 900-904. doi:10.1038/nn896
19. Olausson H, Wessberg J, Morrison I, McGlone F, Vallbo Å. The neurophysiology of unmyelinated tactile afferents. Neurosci Biobehav Rev. 2010; 34 (2): 185-191. doi:10.1016/j.neubiorev.2008.09.011
20. Melchart D, Linde K, Streng A, Reitmayr S, Hoppe A, Brinkhaus B, Becker-Witt C, Wagenpfeil S, Pfaffenrath V, Hammes M, Willich SN, Weidenhammer W. Acupuncture Randomized Trials (ART) in patients with migraine or tension-type headache--design and protocols. Forsch Komplementarmed Klass Naturheilkd. 2003; 10 (4): 179-184. doi:73473
21. Lundeberg T, Lund I, Näslund J, Thomas M. The Emperor's sham - Wrong assumption that sham needling is sham. Acupunct Med. 2008; 26 (4): 239-242. doi:10.1136/aim.26.4.239
22. Birch S. Sham acupuncture is not a placebo treatment - implications and problems in research. Japanese Acupunct Moxibustion. 2012; 8 (1): 4-8.
23. Park J, White A, Lee H, Ernst E. Development of a new sham needle. Acupunct Med. 1999; 17 (2): 110-112. doi:10.1136/aim.17.2.110
24. Streitberger K, Kleinhenz J. Introducing a placebo needle into acupuncture research. Lancet. 1998; 352 (9125): 364-365. doi:10.1016/S0140-6736(97)10471-8
25. Kreiner M, Zaffaroni A, Alvarez R, Clark G. Validation of a simplified sham acupuncture technique for its use in clinical research: A randomised, single blind, crossover study. Acupunct Med. 2010; 28 (1): 33-36. doi:10.1136/aim.2009.001735
26. Takakura N, Yajima H. A placebo acupuncture needle with potential for double blinding - A validation study. Acupunct Med. 2008; 26 (4): 224-230. doi:10.1136/aim.26.4.224
27. Kim S. Creating an instrument for a successful double-blind acupuncture placebo. JAMS J Acupunct Meridian Stud. 2008; 1 (1):36-41. doi:10.1016/S2005-2901(09)60005-4
28. Takakura N, Takayama M, Kawase A, Yajima H. Double blinding with a new placebo needle: A validation study on participant blinding. Acupunct Med. 2011; 29 (3): 203-207. doi:10.1136/aim.2010.002857
29. Takayama M, Yajima H, Kawase A, Homma I, Izumizaki M, Takakura N. The Potential of Double Blinding with Two Placebo Acupuncture Needles: A Randomized Controlled Pilot-Trial. Medicines. 2014; 2 (1): 11-27. doi:10.3390/medicines2010011
30. Zhu D, Gao Y, Chang J, Kong J. Placebo acupuncture devices: Considerations for acupuncture research. Evidence-based Complement Altern Med. 2013; 2013. doi:10.1155/2013/628907
31. Takakura N, Takayama M, Kawase A, Yajima H, Streitberger K. Tapping-in method (Skin Penetration Technique) with a placebo needle for double-blind acupuncture trials. Dtsch Zeitschrift fur Akupunkt. 2013;56 (3): 25-26. doi:10.1016/j.dza.2013.09.008
32. McManus C a, Schnyer RN, Kong J, Nguyen LT, Hyun Nam B, Goldman R, Stason WB, Kaptchuk TJ. Sham acupuncture devices--practical advice for researchers. Acupunct Med. 2007; 25 (1-2): 36-40. doi:10.1136/AIM.25.1-2.36
33. Rebhorn C, Breimhorst M, Buniatyan D, Vogel C, Birklein F, Eberle T. The efficacy of acupuncture in human pain models: A randomized, controlled, double-blinded study. Pain. 2012; 153 (9): 1852-1862. doi:10.1016/j.pain.2012.05.026
34. Park J, White A, Stevinson C, Ernst E, James M. Validating a new sham (placebo) acupuncture device: two randomized controlled trials. Acupunct Med. 2002;20 (2-3): 123-123. doi:10.1136/aim.20.2-3.123
35. To M, Alexander C. The effects of Park sham needles: a pilot study. J Integr Med. 2015; 13 (1): 20-24. doi:10.1016/S2095-4964(15)60153-4